A paper-free path to clinical trials

The Institutional Review Office's Ralph Eickhof and Tanna MacReynold led the development of software that is changing the way Institutional Review Boards operate. Instead bringing stacks of paper to every meeting, Center IRB members and collaborators now just bring their laptops.

Photo by Stephanie Cartier

Leave it to technology and collaborative colleagues at the Hutchinson Center to make a critical but cumbersome process more efficient.

The challenge is twofold. The Center's principal investigators and institutional review boards (IRB) needed liberation from a voluminous, paper-based approach to overseeing human-research studies. The second challenge was to streamline IRB review processes so that investigators can efficiently make their approved studies available to the patient- and research-participant community. The solution: create a customized software alternative.

After rigorously analyzing existing commercial packages and determining they did not meet the IRB's needs, Tanna MacReynold, special-projects manager in the Institutional Review Office, and Ralph Eickhof, systems analyst and programmer, began building a suite of software modules dubbed PIRO — for Professional Institutional Review Operations.

"We took a very strategic approach," said MacReynold. "We started out knowing we wanted a database, an electronic-review process and an electronic-submission process."

Two of the three system modules that MacReynold envisioned are now in use. The first module of PIRO is a database that captures, manages and generates reports for IRB activities and issues. The second module, eReview, serves as a secure portal for the IRB, giving IRB members and staff access to the required documents and agendas. Development of the third module, eSubmission, has just begun. eSubmission will enable investigators to submit forms electronically.

Throughout the development of PIRO, the emphasis has been on addressing both the business and the functional requirements necessary to manage the IRO process — all with the goal of increasing the efficiency and reducing the administrative burden of submission, review, tracking and compliance. Feedback from early users has shown that the current suite is efficiently, intuitively and effectively addressing the needs of those involved in the review process.

The pursuit of an in-house IRB software solution did not go unnoticed. As the Center began integrating the new software with great success, colleagues from other institutions began asking MacReynold for copies. MacReynold asked Rose Beer, then a senior licensing associate with the Center's Industry Relations and Technology Transfer Office, if she could give the software away. Instead of giving the software away, Technology Transfer, under the direction of Spencer Lemons, negotiated an external collaboration with Children's Hospital and Regional Medical Center, the University of Washington and the Benaroya Research Institute at Virginia Mason. Each of these collaborators has now joined the Center in adopting the PIRO database and eReview system and is working with the Center to develop eSubmission. They have also provided additional funding to help with the development of the software. Beer has since become the project manager for eSubmission as well as the collaboration.

"Each member of the collaboration represents a different type of organization, so we are able to identify and address the unique needs of various types of institutions as we develop the system," said Karen Hansen, director of the IRO. "There's also a cost-sharing benefit. One organization going it alone would find it challenging, although we were prepared to do that."

More convenient, paperless meetings

IRBs are federally-mandated committees of doctors, nurses, researchers and community members who work to ensure studies involving human subjects are conducted safely and ethically. Mindful of that obligation, the Center has proactively sought input from both the Office for Human Research Protections and the Association for Accreditation of Human Research Protection Programs to make sure PIRO performs according to government and industry standards, Hansen said.

The software has the potential to dramatically change the way IRBs operate. Instead of bringing a two-foot stack of documents to every meeting, members of the Center's three IRBs now bring a laptop. Besides being more convenient, paperless meetings greatly reduce the IRO's copying budget. The system can also generate automated reports and agendas that previously required manual cutting and pasting. What once could take days to produce can now be produced in as little as 30 seconds — and with less risk of human error.

In addition, the system enables IRB members to discuss reports, agendas and other documents with each other and with IRO staff online prior to meetings. "It does not take the place of the face-to-face discussions and decisions that go on at IRB meetings, but it can make meetings more efficient and productive by taking care of a lot of clarification ahead of time," MacReynold said.

Many individuals have been involved in the development of PIRO, but MacReynold and Eickhof have been at the forefront throughout. MacReynold represents the user community; Eickhof writes code. They've been exchanging questions and ideas for more than three years. "The biggest challenge with this type of project is to understand what it is the user really wants and then develop the appropriate technical solution," Eickhof said.

Pending project completion

The first step was to consolidate separate but frequently redundant databases used by the IRO and the Protocol Office, which inspired the early development of PIRO. Brett Dodson of the Protocol Office was a close collaborator on the early project. Next came the deployment of eReview. Derek Walker, a former Center employee, was project manager during the transition.

With the pending completion of eSubmission, PIRO will fulfill the vision of MacReynold and Eickhof by creating a virtually paper-free alternative to business-as-usual for IRBs. None of it would have been possible, MacReynold said, without strong support from the Center's administration.

Technology Transfer is now exploring ways of making the software more widely available to other users including possibly licensing the software to a commercial entity or expanding the existing collaboration.

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